Lead regulatory activities in line with US, European, ICH, and other applicable requirements to ensure compliance.Manage the day-to-day regulatory activities for all commercial projects, as well as those projects that are currently in development.Determine and communicate appropriate risk analyses and timeline development.Support the global initiatives for products by liaising with Regulatory counterparts in the Europe, Canada and Rest of World.Perform change management to establish the regulatory impact of changes and ensure compliance of registered commitments.Lead liaison in planning and conducting meetings with regulatory agencies for routine meetings and interactions.

Regulatory Affairs and Quality Compliance for CDMO.

• Responsible for alll Quality Activities including but not limited to documentation control, change control, validation, deviation approval, investigation approval, material and component testing and acceptance or rejection, vendor management, customer complaints, GMP training, batch review and release, CAPA and Continuous Quality Improvement.• Provided overall corporate compliance and regulatory affairs direction and strategic guidance for the US, Canada and Puerto Rico markets. • Responsible for keeping management team informed of significant changes in federal and local regulations and guidance policies and potentially significant compliance issues; maintaining issue elevation program; and Provide leadership and direction for significant deviation events that may impact compliance status or significant business risk.• Worked as an active member of Senior Management, including business acquisitions and product development• Worked as Compliance Director for R&D• Strategically navigated product transfer due to critical production work stoppage• Audited Contract Manufacturers in US and Canada• Worked with Health Canada to address compliance issues• Reviewed and developed product labels to meet Plain Language Label requirements• Provided risk assessments to address critical change documentation

Regulatory and Compliance Specialist ensuring quality and compliance with applicable regulatory agencies.• Leading interactions with regulatory agencies (FDA, DEA, FDBPR)• Adherence to all company procedures• Performing and participating in regulatory and client audits.• Managing Quality Agreements• Identifying and remediating regulatory risks.• Assisting clients with regulatory submissions ensuring the quality of their applications• Managed supplier qualifications, vendor audits, and for-cause audits• Document coordination for regulatory filings• Managed elemental impurity risk assessments• Leading interactions with Qualified Person (QP) audits• Managed controlled substance inventory• Manage licensing applications• Developed process for Elemental Impurity reports• Assisted in BLA and ANDA filings from CMO side• Managed internal and external auditing

• Develop and manage standard operating procedures for pharmaceutical development• Train staff for FDA compliance and State regulations• Serve as corporate liaison for compliance audits• Audit third party manufacturers for contract manufacturer organizations both domestically and internationally • Assessment and development of corporate strategy for product lines• Assist international affiliates with global regulatory drug development strategy• Experience with ANDA, CBE-30, and SPL filings• Experience with ICH and FDA standards for cGMP • Member of the International Society for Pharmaceutical Engineering

• Expanded service area and incorporated new services to meet clients’ needs• Performed research, evaluation, and implementation of health planning activities• Managed and monitored Federally Qualified Health Center grants for HRSA• Managed fulltime, part-time, and contract employees for ongoing projects• Created budgets, work plans, and scope of services for new customers• Assisted with the Florida Pharmacy Almanac Project with the University of Florida Department of Pharmacy• Established new clients into health planning activities for IRS 990 requirements• Worked with line of business investors to develop strategic planning needs for health planning and management• Provided Quality Assurance studies for hospitals, federal grants, and local health measures• Developed and implemented hospital utilization data system for hospital and nursing home data to meet ACHA reporting requirements• Directed strategic planning efforts for counties, hospitals, and public health departments• Provided monitoring, coordination, and database management of Alachua County Health Care Board serving as Chair 2012-2014• Served as representative for Alachua County Health Care Facilities Board 2007-2013• Provided training and development as the Information Security Coordinator for local staff

• Performed tracking, interviewing, and case reporting for newly diagnosed clients with infectious diseases.• Monitored and evaluated local community grants for preventative disease management including forecasting, budgeting, and accounting standards• Provided teaching and training programs on diversity, preventative health, and resource management including financial, human resource, and managerial training• Assessed, planned, implemented and evaluated projects for preventative health agencies to improve health outcomes• Reviewed, monitored, and evaluated grants on local and national levels totaling $1.5 million• Developed and implement NACO award winning online outreach program

• Managed Regional Advisory Committee on HIV prevention grants management & needs assessments• Managed subordinate staff for health services and regional committees• Collaborated with community-based organizations to ensure a population-based healthcare approach to reduce health disparities and increase health care access• Established evaluation tools for health disparities initiatives• Created, managed, and established 501c3 Coalition to address health disparities• Monitored and evaluated grants for local health organizations• Collaborated with area resource agencies to reach program goals• Managed daily organizational fulfillment of 501c3 coalition